FDA raises alarm about 'natural' sex supplements

The dietary supplement Rock-It Man was touted as a potent, all-natural solution for the symptoms of erectile dysfunction, one that promised results in just 25 minutes.

But when it was tested in a federal lab earlier this year, Rock-It Man turned out to contain a chemical compound that structurally resembles sildenafil, the active ingredient in the prescription drug Viagra.

In what the Food and Drug Administration calls an escalating public health threat, "natural" supplements are being spiked with undeclared pharmaceutical drugs, often in higher-than-recommended doses. Supplements promising sexual prowess and fulfillment are the most commonly recalled category of tainted products.

So far this year, the FDA has issued public warnings for at least 24 suggestively named sexual supplements because they contained hidden active ingredients that could be harmful. Nearly all were advertised as natural and promised results in less than an hour. The agency also said 10 companies have voluntarily recalled products after they tested positive for unapproved drugs.

In some cases, the supplements were laced with the very prescription drugs they claimed to replace, such as sildenafil. Others contained chemical variants of existing drugs, including those found in Rock-It Man, a product apparently no longer on the market. These compounds, called analogues, lack human safety data and often can slip through testing undetected.

Last year, FDA testing found that a product called Mojo Nights contained five drugs, including two known pharmaceuticals and three variants. Last week, the agency announced it had found a product adulterated with two analogues and an unapproved antidepressant.

The mainstream success of Viagra's little blue pill has fueled demand for cheaper herbal alternatives sold at convenience stores, pharmacies and online. Some men buy them to avoid the hassle or embarrassment of visiting a doctor. Others are seeking a safe and natural alternative to prescription drugs, whose potential side effects include headaches, blurred vision, flushing and nasal congestion.

"People are turning away from talking to practitioners and taking matters into their own hands," said the FDA's Daniel Fabricant, director of the agency's Division of Dietary Supplement Programs.

But pharmaceutical additives — which are never listed on the supplement label — can cause serious side effects, such as low blood pressure. If a consumer has an adverse reaction, it can be difficult for a doctor to help because it is unclear what the supplement may have contained.

The added drugs also can adversely interact with the nitrates found in some prescription medications, such as nitroglycerin. Drugs containing nitrates are often prescribed to men with heart disease, among whom erectile dysfunction is more common.

Pharmaceutical companies complain that their patented and rigorously tested medications are being counterfeited and illegally offered for sale in unsafe ways. The natural products industry, meanwhile, worries that adulterated products give supplements a bad name.

Increasing the risk for unwitting consumers, the FDA has limited regulatory powers over supplements.

In March, the agency warned men not to buy or use Stiff Days after testing found sildenafil in the supplement. The distributor, however, is still selling the product, which is available online at $19.95 for six pills.

"When we purchase these products for resale from overseas, they are advertised as 100 percent herbal, so some may be tainted depending on the source, but I really believe that would be the exception and not the rule," a spokesman for Georgia-based Vertex Technologies wrote in an email.

Other companies have temporarily halted sales. Mojo Nights' website states that "due to severe counterfeit problems ... we have suspended all sales until further notice." A recorded phone message cites a "possible production error" and adds that "we cannot guarantee the authenticity of the product in the marketplace."

One manufacturer's view

Some supplement manufacturers say their herbal products aren't designed to treat a problem but rather to enhance health and wellness, the same way a multivitamin might.

"Picture two marathoner runners, one with just water and the other with electrolyte replenishment that enhances their performance," said Chris Kanik, CEO of a Southern California-based company that sells the "all natural male enhancement" product Affirm XL. "We give men an above-satisfactory sexual experience by supporting their stamina, drive and energy."

The supplement is a blend of vitamins, minerals and herbs, including extracts of ginseng and maca, "horny goat weed," L-arginine, saw palmetto and Tribulus terrestris, according to the label.

But in April, FDA testing showed a batch manufactured in Korea in 2010 was tainted with sulfoaildenfil, a tweaked version of sildenafil.

Kanik said the problem also emerged in his own testing, and he returned products from the adulterated batch to the manufacturer or destroyed them. He said he was unsure how the FDA acquired the product, but he voluntarily issued a recall notice anyway. Affirm XL is now manufactured in New York, he said, and his company tests every batch and lot.

"We've worked hard to reposition Affirm XL as a health and wellness product, not just a sleazy boner pill," said Kanik, who added that he takes the supplement himself, along with other vitamins. "You have to look at what causes the drop in desire; it's not all about an instant erection."

Erectile dysfunction occurs in about 20 percent of men worldwide, said Dr. Joshua Meeks, an assistant professor of urology at Northwestern University's Feinberg School of Medicine.

Normally, sexual stimulation of the nervous system releases nitric oxide in the genitals, triggering an enzyme that creates a compound called cGMP. The net effect relaxes smooth muscle whose contraction usually keeps blood from flowing into the penis.

Viagra and similar drugs inhibit an enzyme that breaks down cGMP, increasing blood flow and producing a more lasting or rigid erection, Meeks said.

Not even an approved pharmaceutical drug can cause an instant erection; if a man isn't aroused, his body won't make the necessary nitric oxide. And despite some fantastic claims by supplement manufacturers, little can be done to increase the length of a man's penis. At best, he can gain a temporary increase in erectile function.

"It's all about the nerve stimulation, allowing blood to get into the penis," Meeks said. "If the nerves don't work well, as in the case of some men with diabetes, you don't get blood flow into the penis."

Men with erectile problems should see a doctor, he said, in part because they can be a sign of cardiovascular disease or other health issues. Testosterone levels decrease with age, which can affect libido, so measuring hormone levels is important to a diagnosis, Meeks said. Therapy can help address any emotional or behavioral factors, such as performance anxiety.

No federal approval

Unlike drugs, supplements aren't required to undergo FDA testing or receive the agency's blessing before the products hit store shelves or are sold online. Instead, the manufacturer is responsible for ensuring the products are safe and effective.

The federal agency can take action once it detects a problem, but critics say by that time the supplement is already in the marketplace.

"It's a regulatory framework that makes no sense," said Dr. Pieter Cohen, an internist at Cambridge Health Alliance and assistant professor at Harvard Medical School who co-authored a commentary on sexual enhancement supplements in JAMA Internal Medicine. "The safety net is absent, so hundreds of products are widely available, the dangers of analogues are completely unknown and the FDA is in a pickle trying to remove these products."

The FDA's medical officers review products based on complaints and random sampling but won't say how often it conducts testing. Finding hidden drugs "is a big problem," Fabricant said, in part because "the target is moving, and it's tougher to hit a moving target."

Chemists create analogues by tinkering with a drug's structure based on information gleaned from patents. At least 46 analogues of sex drugs have been reported, and still more are expected, according to research published by Bastiaan Venhuis of the Dutch Institute for Public Health and Environment.

John Travis, a research scientist for NSF International, which tests and certifies dietary supplements, said chemists start by targeting molecules that have a known mass. "They adjust the mass slightly, so it changes the structure of the molecule … and it's not seen by the instrumentation."

Travis said researchers have developed reference standards for only 28 analogues of sex drugs, which means not all can be identified through testing. "We're working to get all other analogues synthesized, but it does take a lot of time," he said.

Companies may add prescription medications to supplements as a way to attract repeat customers, as herbal or other natural products prove to be ineffective.

Any promise of instant results is a red flag, according to the FDA and the Federal Trade Commission. "No supplement works within 30 minutes," Fabricant said. "That just doesn't exist."

If the product does work, consumers might be getting more than they bargained for. Cohen said he thinks there are two kinds of sexual supplements: those that might be safe but do not work, and those that might work but are not safe.